Does Power & Vaccine Politics Lead to State Usurpation of Ivermectin License?

Ivermectin Games in Indonesia—Power Politics, Vaccine Politics & State Usurpation

As it turns out, Indonesia during the pandemic has been home to one of the largest, most dynamic, yet borderline illegal ivermectin markets worldwide, targeting the SARS-CoV-2 pandemic. That’s because an enterprising, well-known entrepreneur in his 70s capitalized on growing demand in the world’s fourth-most populated nation with the onset of the pandemic over a year ago. In what seems like an inadvertent, almost haphazard move by the central government to exploit positive sales growth of the drug actually appears to be far more about usurping control from the marketplace—and the peoplerestricting access to the drug and importantly, appeasing global influencers, such as the World Health Organization (WHO) and various governments that may be positioning vaccines, for example. How else can such a rollercoaster of a story unfold, one where what appears to be a healthy supply of ivermectin to treat COVID-19 people coupled with a surprisingly stable management of the COVID-19 pandemic to a case where the supply became absolutely constrained directly in parallel with the most massive spike of the pandemic starting in June of 2021. While it would be foolish to suggest this was the result of a conspiracy, it’s certainly understandable how one could come to that conclusion.

TrialSite recently reviewed a piece in the Asia Times titled “Parasitic Politics Plague Ivermectin Use in Indonesia” for what is now a cynical view on the recent government taking of a private business that established a successful ivermectin production and distribution business. For those that think ivermectin can help treat COVID-19 based on the many dozens of studies evidencing promising results, prominent meta-analyses, and numerous countries that allow for off-label use, today this story will disappoint. But TrialSite’s mission is aiming for transparency and accessibility in research and, by extension, healthcare. And with that comes the gritty truth—or our interpretation thereof. We may not be 100 percent accurate here but we suspect the general trajectory is sound. So, here it goes.

Background

With the findings at Australia’s University of Monash that ivermectin absolutely inhibited SARS-CoV-2 in a lab came a widespread interest in this drug as a possible repurposed drug candidate to target the coronavirus.

Many studies across low-and middle-income countries (LMICs)—from small randomized controlled trials to case series and observational studies—produced overwhelmingly positive data that the impact first observed by Australians could be applied to humans at safe dosage levels. After all, ivermectin was already approved by regulatory authorities around the world, including the U.S. Food and Drug Administration (FDA), as an antiparasitic treatment.

By last summer, sales of ivermectin were brisk in Indonesia and the pandemic was well contained. From June through August of last year, the nation only averaged between 1,000 to 2,500 cases per day, not that many given the country’s size of 270 million people.

The Businessman

A seasoned entrepreneur and philanthropist Mr. Haryoseno ran a company in Jakarta called Harsen Laboratories. By last summer, the shrewd businessman saw the potential with ivermectin and made the investments to essentially corner the market in Indonesia with Ivermax 12.

From sourcing raw ingredients and other inputs to optimizing a supply chain, Mr. Haryoseno designed an optimized ivermectin production and distribution apparatus supplying people all over the country, including the influential. He was even contracted to provide ivermectin to the Indonesian Air Force.

Harsen Laboratories ivermectin-based Ivermax 12 product was available at local pharmacies at the price point of $18 for a strip of 10 tablets, and sales continued to soar. Of course, TrialSite cannot prove any correlation with a stabilized pandemic but cases remained relatively contained except for a small wave in December through January, which quickly went down but no major wave occurred until June of this year.

With support from high-level contacts in government, he continued to receive support selling the product for COVID-19 off-label even though it was only indicated for parasite-borne disease. But all eyes were on Indonesia for dual purposes. On the one hand, the government’s state-sponsored enterprise group saw what was a lucrative business to move into and take, while on the other hand, the regulatory authorities had to align with other World Health Organization (WHO) protocols, meaning they needed to get control of ivermectin while preparing for a vaccination program. Ivermectin would only be used in clinical trials positioned by the regulatory agency called BPOM.

The Takeover

Hence the state moved in on Mr. Haryoseno’s business usurping the license for ivermectin. After all, he was breaking the law by distributing the drug for more than just parasite-borne illness. In June of this year, BPOM, the drug regulatory agency there, announced that ivermectin would be used for COVID-19 and that the license would be redirected to the company TrialSite reported on recentlyPT Indofarma. BPOM’s ivermectin declaration can be reviewed here

The State in Control

So when TrialSite reported that ivermectin was authorized and ready for the public, this was actually only a small sliver of the actual story. What really occurred was an orchestrated take-down of the entrepreneur that made the product available to the masses during the pandemic.

Now under firm control of the state-owned enterprise called PT Indofarma, BPOM stepped up its true agenda, which was to ban any and all off-label distribution via this channel. The only thing that ivermectin would be used for is large planned clinical trials with tens of thousands of participants as needed. These, of course, would take time and effort and hence any results would be half a year to a year away.

But what the state didn’t expect was the importance of that know-how, network, and wherewithal needed for a successful ivermectin production supply chain. From the sourcing of main inputs to supplies to manufacturing, the new company was out of its element. Hence the supply of ivermectin essentially dried up.  PT Indofarma and the state via BPOM recently confronted Mr. Haryoseno and Harsen Laboratories to demand their supplies for a start. Not keen that his license was commandeered, Haryoseno has resisted and keeps his ivermectin supply under tight security in warehouses.  Now the government is threatening him with up to ten years in prison and a fine of $70,000.

Summary

What TrialSite initially reported as a breakthrough for ivermectin was, in fact, just the opposite. It was a state-sponsored taking of what was a thriving private business that was distributing ivermectin to the masses. Was the Minister of State Enterprises in cahoots with BPOM to shut down ivermectin access for all except for clinical trials? No one can be certain unless one has an insider. But suffice to say, the plan worked if the goal was to stop mass ivermectin distribution. Certainly, the product still is available on the market; after all, Indonesia is a big country. But the quality is questionable, and there isn’t a major company backing the overall supply chain, ensuring scalable distribution. Note the laws of the land are that BPOM controls the licenses to drugs, and should the people of Indonesia want a different outcome, that would take a legal or political pathway. 

In the meantime, only 5.5% of the nation’s population is fully vaccinated and only 13.4% have received a jab. The number of Delta-driven COVID-19 cases has skyrocketed and the one seemingly available treatment has been usurped from private business and the people.

Responses

  1. This is a great story and I would like to see it documented better. It really could be made into a documentary or feature film. Please keep us updated.